Diabetes MellitusNCT00262704
SimCare: Physician Intervention to Improve Diabetes Care
A study testing Simulated case-based customized learning and Simulated case based customized learning + leader feedback in people with Diabetes Mellitus, run by HealthPartners Institute at 1 site in United States.
Trial summary
This randomized trial will test the hypotheses that (a) a physician opinion leader intervention, (b) a "narrative process trace" physician feedback intervention, or (c) the combined intervention (a + b), are no more effective than (d) usual care in improving the clinical care of adult patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Simulated case-based customized learning and Simulated case based customized learning + leader feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,020 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2001to Sep 2002
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients- Diabetes patients associated with the n=57 physicians were selected according to the following criteria: (1) enrolled in HealthPartners on January 1, 1998, (2) be at least 19 years of age on January 1, 1998, (3) have an established diagnosis of diabetes mellitus in 1998 based on meeting at least one of the following two criteria: (a) have one or more inpatient, or two or more outpatient International Classification of Diseases-9 (ICD-9) diagnostic codes 250.xx for diabetes, or (b) have a filled prescription for a diabetes-specific drug including insulins, sulphonylureas, biguanides, alpha-glucosidase inhibitors, thiazolidinediones, or meglitinides.
- Physicians-All primary care adult care physicians (family physicians or primary care internists) employed full-time at HealthPartners medical groups as of 2000 were eligible for this study.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
HealthPartners Research Foundation
Minneapolis, Minnesota, 55440
About this study
This randomized trial will test the hypotheses that (a) a physician opinion leader intervention, (b) a "narrative process trace" physician feedback intervention, or (c) the combined intervention (a + b), are no more effective than (d) usual care in improving the clinical care of adult patients with type 2 diabetes.
Read the detailed description
This randomized trial will test the hypothesis that (a) an influential physician feedback intervention, (b) a "narrative process trace" feedback intervention, or (c) the combined intervention (a + b), are no more effective than (d) usual care in improving the clinical care of adult patients with diabetes mellitus.
The unit of randomization and the unit of analysis will be primary care physicians who have more than 10 adult patients with diabetes mellitus. The 162 physicians eligible for this study provide care to about 6,804 adults with diagnosed diabetes at 24 primary care clinics. The narrative process trace intervention uses automated medical record (AMR)-mounted clinical cases to assess physicians' diabetes care decisions, with results provided as feedback to physicians. The influential physician feedback intervention emphasizes individualized education of physicians, which will be guided by the narrative process trace in the combined intervention group. Usual care includes the use of a diabetes clinical guideline, use of a diabetes patient registry that provides key clinical data for each adult patient with diabetes, and access to clinic-based diabetes education nurses. We have shown in previous controlled studies that the guideline, diabetes registry, and clinic-based diabetes education nurses have failed to significantly improve diabetes care on a population basis, thus justifying the additional, stronger interventions that now will be tested.
Dependent variables include glycemic control and cardiovascular risk reduction of all 3,360 patients cared for by the 80 study physicians. Secondary analysis will assess rates of screening for microvascular complications. Physicians will be randomized in blocks based on specialty, number of diabetes patients, and years of practice experience. Hierarchical data analysis will be used to accommodate the nested data and propensity scores will be used to correct for selection effects and missing data. Results of this experiment will advance our theoretical understanding of physician behavior change and quantify cost and impact of three specific intervention strategies to improve chronic disease care in the primary care setting. The study will have substantial impact on clinical practice and policy whether the results are positive or negative. If successful, the interventions will be easily disseminated to other primary care practice settings.
- Conditions
- Diabetes Mellitus
- Being tested
- Simulated case-based customized learning, Simulated case based customized learning + leader feedback
- Keywords
- physician intervention, diabetes mellitus, primary care, quality improvement, disease management
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulated case-based customized learningBehavioural
Formal Analysis of Diabetes Practice Style, Using SimCare cases with Process Trace Feedback
Simulated case based customized learning + leader feedbackBehavioural
Formal Analysis of Diabetes Practice Style, Using SimCare cases with Process Trace Feedback + Physician Opinion Leader Feedback Tailored to Provider's Specific Practice Style
| Study group | Role | What they receive |
|---|---|---|
| Group A | No intervention | Control group |
| Group B | Active comparator | Simulated case-based customized learning Receives: Behavioral: Simulated case-based customized learning |
| Group C | Active comparator | Simulated case based customized learning + leader feedback Receives: Behavioral: Simulated case based customized learning + leader feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
glycemic control
Glycosylated hemoglobin (A1c) values and A1c test rates were used to assess glycemic control.
Measured: All A1c and LDL values and test dates were recorded for a defined 12-month period before and after the date of intervention for all diabetes patients under the care of study physicians
lipid control
LDL-cholesterol levels and test rates were used to assess lipid control.
Measured: All A1c and LDL values and test dates were recorded for a defined 12-month period before and after the date of intervention for all diabetes patients under the care of study physicians
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2005 (estimated)
- Study startDec 2001
- Primary completionAug 2002
- Study completionSep 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 2,020 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Patrick J O'Connor, MD MPH, Principal investigator, HealthPartners Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00262704
- Sponsor's protocol ID
- 0001600
- Other IDs
- R01HS010639
- Status last verified
- Aug 2014
- First submitted
- 6 Dec 2005
- Last updated
- 21 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
O'Connor PJ, Sperl-Hillen JM, Johnson PE, Rush WA, Biltz G. Clinical Inertia and Outpatient Medical Errors. In: Henriksen K, Battles JB, Marks ES, Lewin DI, editors. Advances in Patient Safety: From Research to Implementation (Volume 2: Concepts and Methodology). Rockville (MD): Agency for Healthcare Research and Quality (US); 2005 Feb. Available from http://www.ncbi.nlm.nih.gov/books/NBK20513/
PubMed 21249838Dutta P, Biltz GR, Johnson PE, Sperl-Hillen JM, Rush WA, Duncan JE, O'Connor PJ. SimCare: A Simulation Model to Investigate Physician Decision-Making in the Care of Patients with Type 2 Diabetes. In K. Henriksen, J. Battles, D. Lewin, and E. Marks. Advances in Patient Safety: From Research to Implementation. Rockville, MD. Agency for Healthcare Research and Quality (AHRQ). 2005; Vol.4: Programs, Tools, and Products; 179-192. <http://www.ahrq.gov/qual/advances/>
O'Connor PJ, Sperl-Hillen JM, Johnson PE, Rush WA. Identification, Classification, and Frequency of Medical Errors in Outpatient Diabetes Care. In: Henriksen K, Battles JB, Marks ES, Lewin DI, editors. Advances in Patient Safety: From Research to Implementation (Volume 1: Research Findings). Rockville (MD): Agency for Healthcare Research and Quality (US); 2005 Feb. Available from http://www.ncbi.nlm.nih.gov/books/NBK20464/
PubMed 21249801O'Connor PJ. Overcome clinical inertia to control systolic blood pressure. Arch Intern Med. 2003 Dec 8-22;163(22):2677-8. doi: 10.1001/archinte.163.22.2677. No abstract available.
PubMed 14662620O'Connor PJ. Setting evidence-based priorities for diabetes care improvement. Int J Qual Health Care. 2003 Aug;15(4):283-5. doi: 10.1093/intqhc/mzg062. No abstract available.
PubMed 12930043Johnson PE, Veazie PJ, Kochevar L, O'Connor PJ, Potthoff SJ, Verma D, Dutta P. Understanding variation in chronic disease outcomes. Health Care Manag Sci. 2002 Aug;5(3):175-89. doi: 10.1023/a:1019740401536.
PubMed 12363045O'Connor PJ. Patient archetypes, physician archetypes, and tailored diabetes care. J Am Board Fam Pract. 2002 Jul-Aug;15(4):334-7. No abstract available.
PubMed 12150470O'Connor PJ, Sperl-Hillen JM, Johnson PE, Rush WA, Asche SE, Dutta P, Biltz GR. Simulated physician learning intervention to improve safety and quality of diabetes care: a randomized trial. Diabetes Care. 2009 Apr;32(4):585-90. doi: 10.2337/dc08-0944. Epub 2009 Jan 26.
PubMed 19171723
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SimCare: Physician Intervention to Improve Diabetes Care
- ClinicalTrials.gov ID
- NCT00262704
- Acronym / sponsor ID
- 0001600
- Conditions
- Diabetes Mellitus
- Keywords
- physician intervention, diabetes mellitus, primary care, quality improvement, disease management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,020 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Dec 2001
- Primary completion
- Aug 2002 (actual)
- Study completion
- Sep 2002 (actual)
- First posted
- 7 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized trial will test the hypotheses that (a) a physician opinion leader intervention, (b) a "narrative process trace" physician feedback intervention, or (c) the combined intervention (a + b), are no more effective than (d) usual care in improving the clinical care of adult patients with type 2 diabetes.
Detailed description
This randomized trial will test the hypothesis that (a) an influential physician feedback intervention, (b) a "narrative process trace" feedback intervention, or (c) the combined intervention (a + b), are no more effective than (d) usual care in improving the clinical care of adult patients with diabetes mellitus.
The unit of randomization and the unit of analysis will be primary care physicians who have more than 10 adult patients with diabetes mellitus. The 162 physicians eligible for this study provide care to about 6,804 adults with diagnosed diabetes at 24 primary care clinics. The narrative process trace intervention uses automated medical record (AMR)-mounted clinical cases to assess physicians' diabetes care decisions, with results provided as feedback to physicians. The influential physician feedback intervention emphasizes individualized education of physicians, which will be guided by the narrative process trace in the combined intervention group. Usual care includes the use of a diabetes clinical guideline, use of a diabetes patient registry that provides key clinical data for each adult patient with diabetes, and access to clinic-based diabetes education nurses. We have shown in previous controlled studies that the guideline, diabetes registry, and clinic-based diabetes education nurses have failed to significantly improve diabetes care on a population basis, thus justifying the additional, stronger interventions that now will be tested.
Dependent variables include glycemic control and cardiovascular risk reduction of all 3,360 patients cared for by the 80 study physicians. Secondary analysis will assess rates of screening for microvascular complications. Physicians will be randomized in blocks based on specialty, number of diabetes patients, and years of practice experience. Hierarchical data analysis will be used to accommodate the nested data and propensity scores will be used to correct for selection effects and missing data. Results of this experiment will advance our theoretical understanding of physician behavior change and quantify cost and impact of three specific intervention strategies to improve chronic disease care in the primary care setting. The study will have substantial impact on clinical practice and policy whether the results are positive or negative. If successful, the interventions will be easily disseminated to other primary care practice settings.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | No intervention | –Control group |
| Group B | Active comparator | Behavioral: Simulated case-based customized learningSimulated case-based customized learning |
| Group C | Active comparator | Behavioral: Simulated case based customized learning + leader feedbackSimulated case based customized learning + leader feedback |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients- Diabetes patients associated with the n=57 physicians were selected according to the following criteria: (1) enrolled in HealthPartners on January 1, 1998, (2) be at least 19 years of age on January 1, 1998, (3) have an established diagnosis of diabetes mellitus in 1998 based on meeting at least one of the following two criteria: (a) have one or more inpatient, or two or more outpatient International Classification of Diseases-9 (ICD-9) diagnostic codes 250.xx for diabetes, or (b) have a filled prescription for a diabetes-specific drug including insulins, sulphonylureas, biguanides, alpha-glucosidase inhibitors, thiazolidinediones, or meglitinides.
- Physicians-All primary care adult care physicians (family physicians or primary care internists) employed full-time at HealthPartners medical groups as of 2000 were eligible for this study.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simulated case-based customized learningFormal Analysis of Diabetes Practice Style, Using SimCare cases with Process Trace Feedback | Behavioural | Group B |
| Simulated case based customized learning + leader feedbackFormal Analysis of Diabetes Practice Style, Using SimCare cases with Process Trace Feedback + Physician Opinion Leader Feedback Tailored to Provider's Specific Practice Style | Behavioural | Group C |
Primary outcome
glycemic control
Time frame: All A1c and LDL values and test dates were recorded for a defined 12-month period before and after the date of intervention for all diabetes patients under the care of study physicians
Glycosylated hemoglobin (A1c) values and A1c test rates were used to assess glycemic control.
lipid control
Time frame: All A1c and LDL values and test dates were recorded for a defined 12-month period before and after the date of intervention for all diabetes patients under the care of study physicians
LDL-cholesterol levels and test rates were used to assess lipid control.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2014.
- Background: PubMed 21249838O'Connor PJ, Sperl-Hillen JM, Johnson PE, Rush WA, Biltz G. Clinical Inertia and Outpatient Medical Errors. In: Henriksen K, Battles JB, Marks ES, Lewin DI, editors. Advances in Patient Safety: From Research to Implementation (Volume 2: Concepts and Methodology). Rockville (MD): Agency for Healthcare Research and Quality (US); 2005 Feb. Available from http://www.ncbi.nlm.nih.gov/books/NBK20513/
- BackgroundDutta P, Biltz GR, Johnson PE, Sperl-Hillen JM, Rush WA, Duncan JE, O'Connor PJ. SimCare: A Simulation Model to Investigate Physician Decision-Making in the Care of Patients with Type 2 Diabetes. In K. Henriksen, J. Battles, D. Lewin, and E. Marks. Advances in Patient Safety: From Research to Implementation. Rockville, MD. Agency for Healthcare Research and Quality (AHRQ). 2005; Vol.4: Programs, Tools, and Products; 179-192. <http://www.ahrq.gov/qual/advances/>
- Background: PubMed 21249801O'Connor PJ, Sperl-Hillen JM, Johnson PE, Rush WA. Identification, Classification, and Frequency of Medical Errors in Outpatient Diabetes Care. In: Henriksen K, Battles JB, Marks ES, Lewin DI, editors. Advances in Patient Safety: From Research to Implementation (Volume 1: Research Findings). Rockville (MD): Agency for Healthcare Research and Quality (US); 2005 Feb. Available from http://www.ncbi.nlm.nih.gov/books/NBK20464/
- Background: PubMed 14662620O'Connor PJ. Overcome clinical inertia to control systolic blood pressure. Arch Intern Med. 2003 Dec 8-22;163(22):2677-8. doi: 10.1001/archinte.163.22.2677. No abstract available.
- Background: PubMed 12930043O'Connor PJ. Setting evidence-based priorities for diabetes care improvement. Int J Qual Health Care. 2003 Aug;15(4):283-5. doi: 10.1093/intqhc/mzg062. No abstract available.
- Background: PubMed 12363045Johnson PE, Veazie PJ, Kochevar L, O'Connor PJ, Potthoff SJ, Verma D, Dutta P. Understanding variation in chronic disease outcomes. Health Care Manag Sci. 2002 Aug;5(3):175-89. doi: 10.1023/a:1019740401536.
- Background: PubMed 12150470O'Connor PJ. Patient archetypes, physician archetypes, and tailored diabetes care. J Am Board Fam Pract. 2002 Jul-Aug;15(4):334-7. No abstract available.
- Results publication: PubMed 19171723O'Connor PJ, Sperl-Hillen JM, Johnson PE, Rush WA, Asche SE, Dutta P, Biltz GR. Simulated physician learning intervention to improve safety and quality of diabetes care: a randomized trial. Diabetes Care. 2009 Apr;32(4):585-90. doi: 10.2337/dc08-0944. Epub 2009 Jan 26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick J O'Connor, MD MPH principal investigator
HealthPartners Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulated case-based customized learning and Simulated case based customized learning + leader feedback in people with Diabetes Mellitus, run by HealthPartners Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glycemic control (time frame: All A1c and LDL values and test dates were recorded for a defined 12-month period before and after the date of intervention for all diabetes patients under the care of study physicians). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00262704, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2014.